Soluble Bacitracin Methylenedisalicylate
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Soluble Bacitracin Methylenedisalicylate is a mixture of Bacitracin Methylenedisalicylate and Sodium Bicarbonate. It has a potency of NLT 8
Bacitracin Units/mg, calculated on the dried basis.
2 ASSAY
Antibiotics—Microbial Assays 〈81〉
Diluent: 20 g/L of sodium bicarbonate
Sample stock solution: Transfer a suitable amount of Soluble Bacitracin Methylenedisalicylate to a high-speed glass blender jar, add 99.0 mL of Diluent and 1.0 mL of Polysorbate 80, and blend for 3 min.
Test dilution: To a suitable aliquot of the Sample stock solution, add a suitable volume of 0.01 N hydrochloric acid, and dilute with Buffer B.1 to obtain a concentration of bacitracin assumed to be equal to the median dose level of the Standard. [Note—The amount of hydrochloric acid in the Test dilution should be the same as that in the median dose level of the Standard.]
Analysis: Proceed as directed for Bacitracin in Antibiotics—Microbial Assays 〈81〉.
Acceptance criteria: NLT 8 Bacitracin Units/mg on the dried basis
3 SPECIFIC TESTS
pH 〈791〉: 8.0–9.5, in a 25 mg/mL solution
Loss on Drying 〈731〉: Dry 100 mg in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h: it loses
NMT 8.5% of its weight.
4 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers.
Labeling: Label it to indicate that it is for veterinary use only.
USP Reference Standards 〈11〉
USP Bacitracin Zinc RS
